Study of Islet Transplantation in Type 1 Diabetic Kidney Transplant Recipients
Completed · Phase 1/Phase 2
Conditions studied: Diabetes Mellitus, Type I
In brief
The purpose of the study is to learn if islet transplantation is an effective treatment for Type 1 diabetes in people who have had a kidney transplant. The primary objectives of the study are: \- To set up islet transplantation in patients who have had a kidney transplant and who are using an immunosuppressive regimen that works The Secondary objective of the study is: * To find out if successful islet transplantation leads to improved metabolic control and reduced renal complication from diabetes
Key facts
- Study ID
- NCT00888628
- Run by
- Massachusetts General Hospital
- People needed
- 7
- Starts
- 2009-05-01
- Expected to finish
- 2016-08-01
- Last updated by the study team
- 2017-11-29
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Male and female subjects
- Age 18 to 70 years of age
- Have insulin dependent Diabetes Mellitus Type 1
- Are post-renal transplant on maintenance immunosuppression with stable renal function
- HbA1c > 7.5% or < 7.5% and hypoglycemia unawareness
You may not qualify if…
- Weight more than 90 kg
- Insulin requirement > 60 Units/day
- Other (non-kidney) organ transplants except prior failed pancreatic graft.
- Untreated or unstable proliferative diabetic retinopathy
- Presence of de novo antibody production since the renal allograft or either Class I or Class II panel-reactive anti-HLA antibodies
- Active infection
- Negative screen for Epstein-Barr virus (EBV)
- Any history of malignancy except for completely resected squamous or basal cell carcinoma of the skin
- History of Factor V Leiden mutation
- Any coagulopathy or medical condition requiring long-term anticoagulant therapy (e.g. warfarin) after transplantation (low-dose aspirin treatment is allowed) or subjects with international normalized ratio (INR) > 1.5
- Severe co-existing cardiac disease
- Persistent elevation of liver function tests at the time of study entry
- Acute or chronic pancreatitis
- Male subjects with elevation of prostate specific antigen
- Pregnancy
- Positive screen for polyoma (BK) virus
- Untreated hyperlipidemia
- Recent hemorrhagic stroke
- Factors associated with an increased risk of bleeding
- Contact PI for complete Incl-Excl criteria list.
Where it is running
- Massachusetts General Hospital — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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